Recall Z-0311-2025— Datascope Corp.
Class II · Ongoing
Class II FDA medical device recall by Datascope Corp., initiated 2024-09-17. It names 3 FDA 510(k) clearances: K133074, K112327, K041281. Product: MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01. Reason: There is discrepant labeling on the inner and outer packaging of the device..
- Recalling firm
- Datascope Corp.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-09-17
- Firm location
- Fairfield, NJ, United States
510(k) clearances named in this recall
3 on FDA's record- K133074 — MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES
- K112327 — SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES
- K041281 — DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01
Reason for recall
There is discrepant labeling on the inner and outer packaging of the device.
Data sourced from openFDA. This site is unofficial and independent of the FDA.